PRODUCT TECHNICAL DOSSIER SAMe (ADENOSYL METHIONINE) Product Code: P28093 Raw Material Full Name: S-Adenosyl-L-methionine Disulfate Tosylate Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: Sam-e(S-Adenosyl-L-methionine Disulfate Tosylate) This material is Food Grade: Vegan / Vegetarian Status: Suitable for both vegans and vegetarians S, S-Isomer (HPLC): Min 75% Content of Sulfate (SO 4) (HPLC) 23.5% 26.5% CAS Number: 97540-22-2 Molecular Formula for the raw material: C 22H 34N 6O 16S 4 Average Molecular weight: 799.80 Solubility in Water: Freely soluble in water Solubility in Alcohol: Insoluble in ethanol ph: (5% Aqueous Solution) 1.0-2.0 Product Code: P28093 Version: 4 Page 1 of 13
Loss on Drying: Max 3% Residue on Ignition: Max 0.5% Country of Origin: P.R. China. Country of Origin of the Manufacture: P.R. China. Base Source/Start Material: Microorganism. The organism or strains is saccharomyces cerevisiae Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Fermented. Process ingredients Glucose P-Toluene Sulfonic Acid Sulphuric Acid Yeast Powder Methionine Species used: Yeast Solvents used: Water What is the extraction/processing used? What solvents are used and at what ratio s? Certrifugalization, Water Material is: 100% Shelf Life from Date of Manufacture: Min 2 years Storage Conditions: Protect from light, tight container, 20. Product Code: P28093 Version: 4 Page 2 of 13
Appearance (Fine/Crystals/Crystalline/Hygroscopic): White crystalline powder or white crystals Colour: White Flavour/Taste: Characteristic Odour: Characteristic Do any of the parameters change in different seasons? Microbiological Test Total Viable Count: Max 1,000cfu/g Yeast & Moulds: Max 100cfu/g E.Coli: Absent /10g Salmonella: Absent /10g Heavy Metals t more than 10ppm Lead (Pb): t more than 3ppm Cadmium (Cd): t more than 1ppm Mercury (Hg): t more than 0.1ppm Arsenic (As): t more than 2ppm Product Code: P28093 Version: 4 Page 3 of 13
Pharmacopeia Standard Used: USP There are no nuts in this recipe; however we cannot guarantee that the raw materials entering the site are nut free. Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. Product Code: P28093 Version: 4 Page 4 of 13
ALLERGENS Product Free From YES/NO Listed Item on Site at Manufacturer YES/NO Free from Peanuts and Peanut Derivatives (including possible cross contamination) Free from other Nut and Nut Derivatives Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) Free from Sesame Seeds and Sesame Seed Derivatives Free from other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Seeds) Free from Milk and Milk Derivatives (including lactose) Free from Egg and Egg Derivatives Free from Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Gluten (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) Free from Soya and Soya Derivatives Free from Lupin and Lupin Derivatives Free from Mustard and Mustard Derivatives Free from Celery or Celery Derivatives (including Celeriac) Free from Fish and Fish Derivatives Free from Molluscs and their Derivatives Free from Crustaceans and their Derivatives Free from Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre Where applicable, is there risk of cross-contamination? YES/NO or N/A Product Code: P28093 Version: 4 Page 5 of 13
ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Free From YES/NO Listed Item on Site at Manufacturer YES/NO Where applicable, is there risk of crosscontamination? YES/NO or N/A Free from Additives Free from Antioxidants Free from Ethylene Oxide Free from Gelatine Free from Flavourings (Artificial / Nature Identical / Natural / Smoked) Free from Maize / Corn and any Derivatives Free from Legumes / Pulses Free from Rice and Rice Derivatives Free from Added Salt Free from Added Sugar / artificial or natural sweeteners Free from Aspartame Free from BHA / BHT (E320 / E321) Free from Caffeine Free from Colours (Artificial / Nature Identical / Natural / Smoked) Free from Dextrose Free from Dioxins Free from MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) Free from Nucleotides (E627, E630, E631, E635) Free from Polyols (sugar alcohols) Free from Benzoates (E210 / E219) Free from Sorbic Acid (E200, E203) Free from any other Preservatives Free from Ethanol Free from Honey Free from Lactose Free from Yeast and Yeast Derivatives Yeast is used during production Free from All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may include growth/yield hormones, antibiotics etc.) Free from Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) Suitable for Ovo-Lacto Vegetarians Suitable for Vegans Product Code: P28093 Version: 4 Page 6 of 13
NUTRITIONAL DATA Test Calculated Value per 100gm Energy KJ / Kcal 418 Fat 1747 - Of which saturates N/A Carbohydrate N/A - Of which sugars N/A Fibre N/A Protein N/A Salt N/A PRODUCTION FLOW CHART Product Code: P28093 Version: 4 Page 7 of 13
CONFIRMATION OF BSE/TSE STATUS This is to certify that this product complies with all relevant current UK and EU Legislative requirements in regard to Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE) for human food, and so is free of TSE/BSE. This is also to certify that, during the course of their manufacture, the above-mentioned product did not come into contact with any materials, which could be derived from TSE/BSE risk materials. CONFIRMATION OF GM STATUS This is to certify that this product is not manufactured from GM raw materials and is therefore not subject to labelling under regulations 1829/2003/EC and 1830/2003/EC. CONFIRMATION OF NON IRRADIATION STATUS This is to certify that this product, whole or in part, has not been subjected to Ionising Radiation as per European Directives 1999/3/EC. CONFIRMATION OF NANDROLONE STATUS This is to certify that this product, whole or in part, has not come into contact with Nandrolone or any of its precursors in any way. CONFIRMATION OF IOC PRODUCT STATUS This is to certify that this product, whole or in part, has not come into contact with any product/s, which is banned by the IOC (International Olympics Committee) and or WADA. CONFIRMATION OF ANIMAL TESTING STATUS This is to certify that all the products sold by Cambridge Commodities have not been tested on animals in any part of its manufacture in accordance with regulation 86/609/EEC. CONFIRMATION OF PESTICIDES STATUS This is to certify that the above-mentioned product complies with the regulation (EC).396/2005 of 23rd February 2005 and commission Regulation (EU). 559/2011 of 7th June 2011 amending annexes II and III of the above Regulation. CONFIRMATION OF NANOPARTICLE STATUS This is to certify that unless otherwise stated, the above-mentioned product is free of nanoparticles. Commission Recommendation 2011/696/EU, defines as follows: "'Nanomaterial' means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm". Product Code: P28093 Version: 4 Page 8 of 13
MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Chemical formula: Company: Ademetionine Disulfate Tosylate C15H22N6O5S.C7H8O3S.2H2O4S Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: 01353 667258. Email: qa@c-c-l.com Section 2 Hazards Identification 2.1 Classification of the substance or mixture Classification according to EC regulation 1272/2008 (CLP) This substance is classified as not hazardous2.2 Label Elements The product does not need to be labeled in accordance with EC directives or respective national laws. 2.2 Label elements Labelling (CLP) Hazard statements: not applicable Precautionary statements: not applicable 2.3 othe hazards risks worthy of mention. This substance / mixture contains no componets considered to be either persistent, bioaccumulative and toxic(pbt), or every persistent and very bioaccumulative(vpvb) at levels of 0.1% or higher. Section 3 Composition/Information on Ingredients CAS# Chemical Name %(Assay) 97540-22-2 Ademetionine disulfate tosylate 98.0% Hazard Symbols: ne Listed. Risk Phrases: ne Listed. Section 4 Emergency and First Aid Measures Eyes: Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid. Skin: Get medical aid. Flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Ingestion: Get medical aid. Wash mouth out with water. Inhalation: Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid. tes to Physician: Treat symptomatically and supportively. Product Code: P28093 Version: 4 Page 9 of 13
Section 5 Fire-fighting measures General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or chemical foam. Section 6 Accidental Release Measures General Information: Use proper personal protective equipment as indicated in Section 8. Spills/Leaks: Vacuum or sweep up material and place into a suitable disposal container. Section 7 Handling and Storage Handling: Storage: Avoid breathing dust, vapour, mist, or gas. Avoid contact with skin and eyes. Store in a tightly closed container in cool, dry area, recommend storage temperature under 25. Section 8 Exposure Controls/Personal Protection Engineering Controls: Use adequate ventilation to keep airborne concentrations low. Personal Protective Equipment Eyes: Wear chemical goggles Skin: Wear appropriate protective gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to prevent skin exposure. Respirators: Follow the OSHA respirator regulations found in 29CFR 1910.134 or European Standard EN 149. Always use a NIOSH or European Standard EN 149 approved respirator when necessary. Section 9 Physical and Chemical Properties Physical State: powder Appearance: white off-white Odor: odorless. PH: 1~2 (1% aq. sol.) Solubility in water: Freely Soluble. Specific Gravity/Density: Molecular Formula: C15H22N6O5S.C7H8O3S.2H2O4S Molecular Weight: 766.8 Product Code: P28093 Version: 4 Page 10 of 13
Section 10 Stability and Reactivity Chemical Stability: Stable. Conditions to Avoid: Incompatible materials. Incompatibilities with Other Materials: Strong-oxidizing agents. Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, oxides of sulphur, carbon dioxide Hazardous Polymerization: Will not occur. Section 11 Toxicological Information RTECS#: CAS 97540-22-2: MC0556000 LD50/LC50: CAS# 97540-22-2: Oral, mouse: LD50 = 5000 mg/kg. Carcinogenicity: - Ademetionine disulphate Tosylate. t listed by ACGIH, IARC, NIOSH, NTP, or OSHA. Section 12 Ecological Information information is available. Section 13 Disposal Considerations Dispose of in a manner consistent with federal, state, and local regulations. Section 14 Transport Information IATA: IMO: RID/ADR: Ademetionine disulphate Tosylate not regulated as dangerous goods. Ademetionine disulphate Tosylate is not regulated as dangerous goods. Ademetionine disulphate Tosylate is not regulated as dangerous goods. Section 15 Regulatory Information European/International Regulations: European Labelling in Accordance with EC Directives Hazard Symbols: t available Risk Phrases: Safety Phrases: S 24/25 Avoid contact with skin and eyes. WGK (Water Danger/Protection) CAS# 70-18-8: 1 United Kingdom Occupational Exposure Limits Product Code: P28093 Version: 4 Page 11 of 13
United Kingdom Maximum Exposure Limits Canada CAS# 97540-22-2: is listed on Canada's DSL List. CAS# 97540-22-2: is not listed on Canada's Ingredient Disclosure List. Exposure Limits US FEDERAL TSCA CAS# 97540-22-2: is listed on the TSCA inventory. Section 16 Other Information MSDS Creation Date: 01/01/2010 Revision #0 Date: Original. This advice is given by Cambridge Commodities Ltd who accepts no legal liability for it. The information contained herein is based on the present state of our knowledge and is intended to describe our products from the point of view of safety requirements. It should not therefore be construed as guaranteeing specific properties. Individuals working with chemicals should consider all chemicals to be potentially hazardous even if their individual hazards may be uncharacterised or unknown. This Information provided in this document is subject to change and the batch specific Certificate of Analysis should always be referenced. To be used as per local legislation. Product Code: P28093 Version: 4 Page 12 of 13
Change History Version Change Customer tification required / 1 First Issue N/A 2 The following has been updated, due to the supplier updating their specification: - Shelf Life from Date of Manufacture has been updated from 3 Years to Min 2 Years - Loss on Drying has been updated from Max 0.5% to Max 3% - Residue on Ignition has been updated from Max 0.1% to Max 0.5% - Lead (Pb) has been updated from Max 1ppm to Max 3ppm - Cadmium (Cd) has been updated from Max 0.1ppm to Max 1ppm 3 Updated Allergens and additives/contaminants/dietary requirements tables to amend clerical error. 4 Added Content of S, S-Isomer and Content of Sulfate. Added Vegan and Vegetarian Status. Updated Solvent Used from Ethanol to Water. Updated Food Intolerance Information. Changed Pharmacopeia Used from JP to USP. Document Approval Originator Job Title Quality Specialist Approver Job Title Quality Specialist Casey White Casey White (Feb 6, 2017) Lucia Valle Lucia Valle (Feb 6, 2017) Product Code: P28093 Version: 4 Page 13 of 13
P28093-SAMe(S-Adenosyl Me thionine)-technical Dossier Adobe Sign Document History 02/06/2017 Created: 02/06/2017 By: Status: Transaction ID: Casey White (casey.white@c-c-l.com) Signed CBJCHBCAABAAmfdiXsLqPuHTqu7agX46vnWLIu6k1dYx "P28093-SAMe(S-Adenosyl Methionine)-Technical Dossier" H istory Document uploaded by Casey White (casey.white@c-c-l.com) from Acrobat 02/06/2017-2:27:24 AM PST- IP address: 81.145.42.226 Document signed in Acrobat by Casey White (casey.white@c-c-l.com) Signature Date: 02/06/2017-2:27:56 AM PST - Time Source: server- IP address: 81.145.42.226 Document emailed to Lucia Valle (Lucia.Valle@c-c-l.com) for signature 02/06/2017-2:27:57 AM PST Document viewed by Lucia Valle (Lucia.Valle@c-c-l.com) 02/06/2017-4:11:03 AM PST- IP address: 81.145.42.226 Document e-signed by Lucia Valle (Lucia.Valle@c-c-l.com) Signature Date: 02/06/2017-4:12:40 AM PST - Time Source: server- IP address: 81.145.42.226 Signed document emailed to Casey White (casey.white@c-c-l.com) and Lucia Valle (Lucia.Valle@c-c-l.com) 02/06/2017-4:12:40 AM PST